A Prospective, Multicenter, Observational Cohort Study Assessing the Efficacy and Safety of Radiotherapy-sensitized Immunotherapy in Advanced Breast Cancer
Recruiting · NCT06776861 · Observational (researchers observe without assigning treatment) · Lead sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
View the official record on ClinicalTrials.gov →Interventions studied
PD-1 / PD-L1 monoclonal antibody
What this trial is about
A prospective, multicenter, observational cohort study assessing the efficacy and safety of radiotherapy-sensitized immunotherapy in advanced breast cancer.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- Subjects are eligible for inclusion in the study only if all the following criteria apply:
- Men or women who are 18 years of age or older on the day of signing the informed consent;
- Patients with advanced breast cancer that is inoperable or has metastasized, confirmed by histology or cytology;
- Patients who, after MDT discussion at the metastatic breast cancer stage, are considered suitable for radiotherapy and have completed radiotherapy;
- Patients who have previously received and continue to use immunotherapy, or are planned to receive immunotherapy, and are scheduled to receive a systemic treatment regimen including immunotherapy as chosen by the physician within 3 weeks after completing radiotherapy;
- Patients with a traceable medical history during treatment;
- Subjects who are able to sign an informed consent to participate in the study.
Exclusion criteria
- Subjects with brain metastases or leptomeningeal metastases; if there are any suspected symptoms or signs of CNS involvement, they should be excluded by a cranial MRI scan;
- Have not signed the informed consent form;
- Pregnant or lactating women;
- Other conditions deemed unsuitable for inclusion in the study by the investigator.
Where it is running
1 location listed.
- Cancer Hospital, Chinese Academy of Medical Sciences - Beijing, Beijing Municipality, China